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Good early results seen with anti-VEGF refillable port delivery system
CHICAGO — First-in-human results on the efficacy of a refillable port delivery system filled with ranibizumab for the treatment of age-related macular degeneration are comparable to those reported for once-monthly intravitreal injections of 0.5-mg ranibizumab, a speaker said here.
Even if patients do not receive treatment each month, they still must adhere to a strict once-monthly monitoring regimen, Anat Loewenstein, MD, said at Retina Subspecialty Day preceding the joint meeting of the American Academy of Ophthalmology and Asia-Pacific Academy of Ophthalmology.
To eliminate this burden, Loewenstein and colleagues examined a refillable non-biodegradable Lucentis (ranibizumab, Genentech) port delivery system (PDS, Genentech) that is specifically customized for standard ranibizumab delivery (10 mg/mL) over an extended period of time.
A phase 1 uncontrolled trial, completed in Latvia, tested the efficacy and safety of the PDS and included 20 treatment-naïve AMD patients who were evaluated on a monthly basis. Each PDS was initially filled with 250 µg of ranibizumab.
The PDS was surgically implanted in the pars plana below the conjunctiva, with no scleral sutures needed.
Seventy-seven mild and moderate study-related adverse events were observed; four significant adverse events, including one case of endophthalmitis, two vitreous hemorrhages and one traumatic cataract, were associated with the implantation procedure.
The device was sustained in the eye for the 12-month duration of the trial, Loewenstein said. The PDS can be seen inside the eye, but it is not in the optical access and can be seen only after pupillary dilation.
Treatment with the PDS resulted in an improvement in BCVA that was comparable to treatment with monthly injections. A sustained reduction in macular thickness and choroidal neovascularization leakage was also observed.
Disclosure: Loewenstein is a consultant for Allergan, Bayer, ForSight Labs, Notal Vision and Novartis.
